Description

Pyridoxine Impurity 32 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Pyridoxine (Vitamin B6). It is primarily required by analytical laboratories and quality control departments in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pyridoxine HCl and related drug substances and products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified limits.
• Regulatory Compliance & Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products in Pyridoxine formulations under various stress conditions.
• Research & Development: Supports chemical research into the synthesis, metabolism, and degradation pathways of Vitamin B6 and its analogs.

Basic Information

Product Name	Pyridoxine Impurity 32
CAS No.	19203-53-3
Molecular Formula	C8H11NO3
Molecular Weight	169.18 g/mol
Synonyms	4-Pyridoxic acid lactone; 5-Hydroxy-6-methylpyridine-3,4-dicarboxylic acid 4-lactone; 3-Hydroxy-4,5-bis(hydroxymethyl)-2-methylpyridine; Pyridoxine degradation product; Pyridoxine related compound; Vitamin B6 Impurity; 5-Hydroxy-6-methyl-3,4-pyridinedicarboxylic acid 4-lactone
EINECS	Contact for details

Quality Control

Every batch of Pyridoxine Impurity 32 is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and impurity profile. Our quality protocols are designed to meet the stringent requirements of pharmaceutical R&D and QC laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.